Double-blind, Randomized, Controlled, Four Treatment Four Period Cross-over Trial on Glycemic Response, Excretion of Gluconate and Tolerability of Two Doses of Low Sugar Apple Juice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- iAUC glucose 500
研究概览
简要总结
Single center, double-blind, randomized controlled cross-over trial with four treatments and four time points.
The study has three primary objectives. The first primary objective is to confirm the reduction of postprandial glycemic and insulinemic response after consumption of 500 ml glucose-free apple juice compared to 500 ml untreated apple juice as could be shown in a previous study
详细描述
Single center, double-blind, randomized controlled cross-over trial with four treatments and four time points.
The study has three primary objectives. The first primary objective is to confirm the in a previous study shown reduction of postprandial glycemic and insulinemic response after consumption of 500 ml glucose-free apple juice compared to 500 ml untreated apple juice.
The second primary objective is to show the reduction of postprandial glycemic response after consumption of 250 ml glucose-free apple juice compared to 250 ml untreated apple juice.
The third primary objective is to show the reduction of insulinemic response after consumption of 250 ml glucose-free apple juice compared to 250 ml untreated apple juice.
Secondary objectives include safety aspects, specifically the occurrence of diarrhoea in all four treatment groups, differences between treatment groups on the Bristol Stool Forms Scale, gastro-intestinal symptoms and laboratory parameters. In addition, gluconate excretion and excreted portion of ingested gluconate are of interest as well as faecal pH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The test products (verum and control) are similar in flavour, color, texture, appearance and identical in packaging to ensure the double-blind, controlled design of the study.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males aged ≥ 18y
- •Impaired fasting glucose (IFG)
- •Written informed consent
- •Consent to collect stools and urine four times for three days
排除标准
- •Subjects currently enrolled in another clinical study
- •Subjects having finished another clinical study within the last 4 weeks before inclusion.
- •Subjects having participated in the study HB-RCT1-2015
- •Hypersensitivity, allergy or idiosyncratic reaction to apple, apple juice or other apple containing food
- •Acute or chronic infections
- •Renal insufficiency
- •Gastrointestinal illness
- •No stools of type 5-7 of Bristol Stool Form Scale within the last week before inclusion
- •History of gastrointestinal surgery
- •Known fructose intolerance
- •Overt diabetes mellitus
- •Endocrine disorders
- •Any disease or condition which might compromise significantly the hematopoietic, renal, endocrine, pulmonary, hepatic, cardiovascular, immunological, central nervous, dermatological or any other body system with the exception of the conditions defined by the inclusion criteria
- •History of hepatitis B and C
- •History of HIV infection
- •History of coagulation disorders or pharmaceutical anti-coagulation (with the exception of acetylsalicylic acid)
- •Regular medical treatment including OTC, which may have impact on the study aims (e.g. gluconic acid-containing OTCs, antidiabetic drugs, laxatives etc.)
- •Major cognitive or psychiatric disorders
- •Subjects who are scheduled to undergo hospitalization during the study period
- •Eating disorders (e.g. anorexia, bulimia) or special diets (e.g. vegan, vegetarian)
- •Present drug abuse or alcoholism
- •Legal incapacity
研究组 & 干预措施
control 250
250 ml conventional apple juice produced by a general apple juice production process (free glucose 17g/l)
干预措施: 250 ml conventional apple juice (Other)
verum 500
500 ml low sugar apple juice manufactured from conventional apple juice via a series of enzymatic reactions that end up in a final content of free glucose less than 0,5 g/l.
干预措施: 500 ml glucose-depleted apple juice (Other)
control 500
500 ml conventional apple juice produced by a general apple juice production process (free glucose 17g/l)
干预措施: 500 ml conventional apple juice (Other)
verum 250
250 ml low sugar apple juice manufactured from conventional apple juice via a series of enzymatic reactions that end up in a final content of free glucose less than 0,5 g/l.
干预措施: 250 ml glucose-depleted apple juice (Other)
结局指标
主要结局
iAUC glucose 500
时间窗: 120 min after ingestion
Incremental AUC (iAUC120) of blood glucose levels (according to FAO/WHO) after 500 ml juice
iAUC glucose 250
时间窗: 120 min after ingestion
Incremental AUC (iAUC120) of blood glucose levels (according to FAO/WHO) after 250 ml juice
iAUC insulin 500
时间窗: 120 min after ingestion
iAUC insulin 500
iAUC insulin 250
时间窗: 120 min after ingestion
iAUC insulin 250
次要结局
- gastro-intestinal symptoms(before and 60 and 120 minutes after ingestion with respect to the last 2 hours)
- diarrhea(before and 60 and 120 minutes after ingestion with respect to the last 2 hours)